DISCUSSION
These analyses provide useful insights on the impact of maintenance treatment on BSA. They demonstrated that Cal/ BD foam once daily for four weeks significantly reduced BSA, an effect that was sustained over 52 weeks. Mean BSA was lower throughout the maintenance phase in the proactive arm compared to the reactive arm. Area under the curve BSA which compressed numerous observations to give a single estimate4 was statistically significantly lower for patients in the proactive arm (FAS and completers). The difference in mean BSA and AUC values for dropouts was not statistically significant across treatment arms. This could be due to many dropouts (25%) occurring in combination with a relapse which could not be managed with rescue therapy.
Differences in AUC BSA during remission and relapse were explored since AUC analysis over the whole period of 52 weeks may not reflect this variation in detail. This sub-analysis was more diagnostic than a proper assessment of treatment efficacy, since proactive management led to fewer relapses compared to reactive management,1 it further illuminated the benefit provided by proactive management. Namely, patients in remission by proactive management had significantly lower BSA than patients in remission under a reactive management strategy.
Future research could assess the impact of proactive management with Cal/BD foam on BSA beyond 52 weeks, as there is a lack of evidence for longer term outcomes with topical treatments.5
Differences in AUC BSA during remission and relapse were explored since AUC analysis over the whole period of 52 weeks may not reflect this variation in detail. This sub-analysis was more diagnostic than a proper assessment of treatment efficacy, since proactive management led to fewer relapses compared to reactive management,1 it further illuminated the benefit provided by proactive management. Namely, patients in remission by proactive management had significantly lower BSA than patients in remission under a reactive management strategy.
Future research could assess the impact of proactive management with Cal/BD foam on BSA beyond 52 weeks, as there is a lack of evidence for longer term outcomes with topical treatments.5
CONCLUSIONS
Treatment with Cal/BD foam once daily for four weeks significantly reduced mean BSA. This effect was maintained with proactive or reactive management for 52 weeks. Proactive management resulted in consistently lower BSA compared to reactive management throughout the study period. The difference between treatment arms was statistically significant in the overall population and in study completers, but not in dropouts or in patients experiencing relapse. Therefore, in addition to longer time to first relapse, fewer relapses, and more time in remission,1 proactive management results in lower BSA compared to reactive management.
DISCLOSURES
Henrik Thoning, Nanna Nyholm, and Bibi Petersen are employees at LEO Pharma.
Linda Stein Gold has been an investigator, speaker, consultant or an advisory board member for AbbVie Inc., Amgen, Arcutis Biotherapeutics, Inc., Bristol-Myers Squibb, Celgene, Eli Lilly and Company, LEO Pharma, Mayne Pharma, Novartis, Ortho Dermatologics Inc., Pfizer, and Sun Pharmaceutical Industries Ltd.
Amrit Takhar has received grants/research support and/or been 100 a medical advisor for the following companies/organizations: Amgen, AstraZeneca, Bayer, Boehringer Ingelheim, Cambridge and Peterborough Clinical Commissioning Group, Daiichi Sankyo, Dermal Laboratories, GlaxoSmithKline, LEO Pharma, Merck, National Institute of Health Research UK, Novartis, Pfizer, Roche, Sanofi, and University of Cambridge.
Funding source: This study was funded by LEO Pharma.
Linda Stein Gold has been an investigator, speaker, consultant or an advisory board member for AbbVie Inc., Amgen, Arcutis Biotherapeutics, Inc., Bristol-Myers Squibb, Celgene, Eli Lilly and Company, LEO Pharma, Mayne Pharma, Novartis, Ortho Dermatologics Inc., Pfizer, and Sun Pharmaceutical Industries Ltd.
Amrit Takhar has received grants/research support and/or been 100 a medical advisor for the following companies/organizations: Amgen, AstraZeneca, Bayer, Boehringer Ingelheim, Cambridge and Peterborough Clinical Commissioning Group, Daiichi Sankyo, Dermal Laboratories, GlaxoSmithKline, LEO Pharma, Merck, National Institute of Health Research UK, Novartis, Pfizer, Roche, Sanofi, and University of Cambridge.
Funding source: This study was funded by LEO Pharma.
REFERENCES
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4. Phà m B, Cranney A, Boers M, et al. Validity of area-under-the-curve analysis to summarize effect in rheumatoid arthritis clinical trials. The Journal of Rheumatology 1999;26 3:712-6.
5. Segaert S, Calzavara-Pinton P, de la Cueva P, et al. Long-term topical management of psoriasis: the road ahead. J Dermatol Treat 2020:1-10.
2. Wu JJ, Schrader A, McLean RR, et al. improvement in body surface area is associated with better quality of life among patients with psoriasis in the Corrona Psoriasis Registry. J Am Acad Dermatol 2020.
3. Sendrasoa FA, Razanakoto NH, Ratovonjanahary V, et al. quality of life in patients with psoriasis seen in the department of dermatology, Antananarivo, Madagascar. BioMed Research International 2020:9292163.
4. Phà m B, Cranney A, Boers M, et al. Validity of area-under-the-curve analysis to summarize effect in rheumatoid arthritis clinical trials. The Journal of Rheumatology 1999;26 3:712-6.
5. Segaert S, Calzavara-Pinton P, de la Cueva P, et al. Long-term topical management of psoriasis: the road ahead. J Dermatol Treat 2020:1-10.
AUTHOR CORRESPONDENCE
Linda Stein Gold MD lstein1@hfhs.org
